Pfizer-BioNTech Comirnaty COVID-19 vaccine

All COVID-19 vaccines authorized in Canada are proven safe, effective and of high quality.

Name: Pfizer-BioNTech Comirnaty® COVID-19 vaccine

Manufacturer: BioNTech Manufacturing GmbH

Type: mRNA

Status: Approved by Health Canada

Approved for: Primary series in individuals age 6 months and older or as a booster dose in individuals age 5 to 11 years as well as 16 years and older (Pfizer-BioNTech Comirnaty® COVID-19 vaccine)

As a bivalent booster dose (Pfizer-BioNTech Comirnaty® Original and Omicron BA.4/BA.5 in individuals age 12 years and older

As a bivalent booster dose (Pfizer-BioNTech Comirnaty® Original and Omicron BA.1 in individuals age 12 years and older

How it's given: Injection in muscle (usually the upper arm)

Number of doses: 2 doses for a primary series in ages 5 years and older or 3 doses for a primary series in ages 6 months to under 5 years. 1 dose for the booster and bivalent booster.

 

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Who the vaccine is approved for

Pfizer-BioNTech Comirnaty® COVID-19 vaccine

The vaccine is approved for people who are 6 months of age and older. Its safety and effectiveness in people younger than 6 months of age have not yet been established. This vaccine is also approved as a booster for people age 5 to 11 years as well as 16 years and older.

Pfizer-BioNTech Comirnaty® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine

The Pfizer-BioNTech Comirnaty® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine is approved as a booster for people who are 12 years of age and older. Its safety and effectiveness in younger people has not yet been established.

Pfizer-BioNTech Comirnaty® Original and Omicron BA.1, bivalent COVID-19 vaccine

The Pfizer-BioNTech Comirnaty® Original and Omicron BA.1, bivalent COVID-19 vaccine is approved as a booster for people who are 12 years of age and older. Its safety and effectiveness in younger people has not yet been established.

Effectiveness

Clinical trials showed that beginning 1 week after the second dose, the Pfizer-BioNTech Comirnaty® COVID vaccine was about:

Effectiveness data supporting the authorization in children ages 6 months to under 5 years are based on a comparison of immune responses in this age group to individuals ages 16 to 25 years. The data determined that the immune response to the vaccine for both age groups was comparable to the immune response of the older participants.

The Pfizer-BioNTech Comirnaty® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine was shown to increase the immune response against the Omicron BA.4/BA.5 variants. This means that the booster is expected to offer protection against these variants.

The Pfizer-BioNTech Comirnaty® Original and Omicron BA.1, bivalent COVID-19 vaccine was shown to increase the immune response against the Omicron BA.1 variant. This means that the booster is expected to offer protection against this variant.

Dosage

Primary series

The dosing schedule approved by Health Canada is to give 2 doses (30 micrograms each for ages 12 and older or 10 micrograms each for ages 5 to 11) 21 days apart, based on evidence from clinical trials. The dosing for 6 months to less than 5 years is a 3-dose primary series of 3 micrograms each of the vaccine. The initial 2 doses are administered 21 days apart followed by a third dose administered at least 8 weeks after the second dose.

Dose volume depends on which series of the vaccine is administered. The dose for individuals 12 years of age and older (30 micrograms) is 3 times the dose used for children 5 to 11 years of age (10 micrograms) and 10 times the dose used for children 6 months to less than 5 years of age (3 micrograms).

Children aged 4 who will turn 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination. The interval between doses is determined by the child’s age at the start of the vaccination series.

Booster doses

A single booster dose of the Pfizer-BioNTech Comirnaty®COVID-19 vaccine may be administered in individuals 5 years of age and older at least 6 months after completing their primary vaccine series (30 micrograms each for ages 12 and older or 10 micrograms each for ages 5 to 11).

A booster dose (30 micrograms) of the Pfizer-BioNTech Comirnaty® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine may be administered in individuals 12 years of age and older at least 3 to 6 months after completing their primary vaccine series or a previous booster dose.

A booster dose (30 micrograms) of the Pfizer-BioNTech Comirnaty® Original and Omicron BA.1, bivalent COVID-19 vaccine may be administered in individuals 12 years of age and older at least 3 to 6 months after completing their primary vaccine series or a previous booster dose.

The currently available vaccine products with purple caps and a purple label border or grey caps with a grey label border are used to prepare the dose for individuals 12 years of age and older. The grey caps and a grey label border have improved stability with a change in buffer and are the only vials that do not require dilution to make handling and administration easier. The vaccine vials for dosing in ages 5 to 11 years have orange caps and an orange border on the label. The vaccine vials for dosing in ages 6 months to less than 5 years have maroon caps and maroon label border. This helps to distinguish these vials from those with the higher dose. This also makes it easier to administer smaller doses to younger children.

Your province or territory decides when people receive their doses of the vaccine. These decisions are based on public health recommendations and the latest evidence.

Learn more about:

COVID-19: How provinces and territories make decisions about how, who and when to vaccinate

Mixed dose schedules

A different vaccine may be offered for your second dose. For example, you may have received Pfizer-BioNTech Comirnaty® as your first dose and be offered Moderna Spikevax® as your second. This is known as a mixed vaccine series.

The National Advisory Committee on Immunization (NACI) recommends an mRNA vaccine (Pfizer-BioNTech Comirnaty® or Moderna Spikevax®) should be offered for your second dose.

Learn more about:

Vaccine ingredients

Medicinal ingredient

The mRNA sequence from the Pfizer-BioNTech Comirnaty® COVID-19 vaccine is also included in the Pfizer-BioNTech Comirnaty® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine. The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.4/BA.5 variants.

The mRNA sequence from the Pfizer-BioNTech Comirnaty® COVID-19 vaccine is also included in the Pfizer-BioNTech Comirnaty® Original and Omicron BA.1, bivalent COVID-19 vaccine. The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.1 variant.

Other ingredients (ages 12 and older) (vials with purple cap and purple label border)

Other ingredients (vials with grey cap and grey label border, orange cap and orange label border, or maroon caps and maroon label border)

Footnote *

Ages 6 months and older Pfizer/BioNTech Comirnaty® modified formulation of BNT162b2: This modified formulation offers an improved stability profile and is easier to use at administration sites. It uses a Tris-sucrose buffer instead of phosphate-buffered saline (PBS) and excludes sodium chloride and potassium chloride. The change in buffer is not considered clinically significant.

Return to footnote * referrer

This vaccine does not contain common food allergens, such as eggs, shellfish, gluten or nuts.

Possible side effects

After getting vaccinated, it's common to have temporary side effects. These can last a few hours to a few days after vaccination.

This is the body's immune response, as it's working hard to build protection against the disease.

Common vaccine side effects may include:

Symptoms at the injection site, such as: More general symptoms, such as:
  • redness
  • soreness
  • swelling
  • chills
  • fatigue
  • joint pain
  • headache
  • mild fever
  • muscle aches

Most commonly reported symptoms specific to 6 months to less than 24 months:

  • irritability/crying
  • loss of appetite
  • fever
  • swelling of the lymph nodes

Rare vaccine side effects

Rare reactions that have been reported and confirmed after taking an mRNA vaccine are:

A severe allergic (anaphylaxis) reaction following vaccination is also rare. Signs and symptoms of anaphylaxis may include:

Call emergency services if you develop or witness any serious symptoms that could be an allergic reaction after vaccination.

Reporting a possible serious reaction

Contact your health care provider if you experience:

Health care providers must report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.

Reported allergic reactions and side effects to COVID-19 vaccines are published weekly in our Reported side effects following COVID-19 vaccination report.

Vaccine review, approval and monitoring

Health Canada's independent drug review process is recognized around the world for its high standards and rigor. Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective. The benefits must also outweigh any risks.

The Pfizer-BioNTech COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19. The interim order expired on September 16, 2021. On this date, Pfizer-BioNTech Comirnaty®transitioned to an authorization under the Food and Drug Regulations.

Find detailed technical information such as the product monograph and the regulatory decision summary:

As COVID-19 vaccines are administered across Canada, our safety monitoring is ongoing. The Public Health Agency of Canada, Health Canada, and provincial and territorial health authorities continue to:

Learn about the side effects we're currently monitoring.

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